Notice2022-24232
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Postmarket Surveillance of Medical Devices
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
November 7, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Full Text
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<title>Federal Register, Volume 87 Issue 214 (Monday, November 7, 2022)</title>
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[Federal Register Volume 87, Number 214 (Monday, November 7, 2022)]
[Notices]
[Pages 67045-67046]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-24232]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-0557]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Postmarket
Surveillance of Medical Devices
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.
DATES: Submit written comments (including recommendations) on the
collection of information by December 7, 2022.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to <a href="https://www.reginfo.gov/public/do/PRAMain">https://www.reginfo.gov/public/do/PRAMain</a>. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. The OMB control number for
this information collection is 0910-0449. Also include the FDA docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-8867,
<a href="/cdn-cgi/l/email-protection#8ddddfccdef9ecebebcdebe9eca3e5e5fea3eae2fb"><span class="__cf_email__" data-cfemail="2b7b796a785f4a4d4d6b4d4f4a05434358054c445d">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.
Postmarket Surveillance of Medical Devices--21 CFR Part 822
OMB Control Number 0910-0449--Extension
Section 522 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C.
360l) authorizes FDA to require a manufacturer to conduct postmarket
surveillance (PS) of any device that meets the criteria set forth in
the statute. The PS regulation establishes procedures that FDA uses to
approve and disapprove PS plans. The regulation provides instructions
to manufacturers, so they know what information is required in a PS
plan submission. FDA reviews PS plan submissions in accordance with 21
CFR 822.15 through 822.19 of the regulation, which describe the grounds
for approving or disapproving a PS plan. In addition, the PS regulation
provides instructions to manufacturers to submit interim and final
reports in accordance with 21 CFR 822.38. Respondents to this
collection of information are those manufacturers that require PS of
their products.
In the Federal Register of May 27, 2022 (87 FR 32169), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
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Number of Average
21 CFR part/activity Number of responses per Total annual burden per Total hours
respondents respondent responses response
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Sec. Sec. 822.9 and 822.10; 5 1 5 120 600
PS submission..................
Sec. 822.21; Changes to PS 9 1 9 40 360
plan after approval............
Sec. 822.28; Changes to PS 1 1 1 8 8
plan for a device that is no
longer marketed................
Sec. 822.29; Waiver........... 0 0 0 40 0
Sec. 822.30; Exemption request 0 0 0 40 0
Sec. 822.38; Periodic reports. 17 3 51 40 2,040
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Total....................... .............. .............. .............. .............. 3,008
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Explanation of Reporting Burden Estimate: The burden captured in
table 1 is based on the data from FDA's internal tracking system. 21
CFR 822.26, 822.27, and 822.34 do not constitute information collection
subject to review
[[Page 67046]]
under the PRA because it entails no burden other than that necessary to
identify the respondent, the date, the respondent's address, and the
nature of the instrument (see 5 CFR 1320.3(h)(1)).
Table 2--Estimated Annual Recordkeeping Burden \1\
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Number of Average
21 CFR part/activity Number of records per Total annual burden per Total hours
recordkeepers recordkeeper records recordkeeping
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Sec. 822.31; Manufacturer 5 1 5 20 100
records........................
Sec. 822.32; Investigator 15 1 15 5 75
records........................
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Total....................... .............. .............. .............. .............. 175
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
Explanation of Recordkeeping Burden Estimate: FDA expects that at
least some of the manufacturers will be able to satisfy the PS
requirement using information or data they already have. For purposes
of calculating burden, however, FDA has assumed that each PS order can
only be satisfied by a 3-year clinically based surveillance plan, using
three investigators. These estimates are based on FDA's knowledge and
experience with PS.
We have adjusted our burden estimate, which has resulted in a
decrease to the currently approved burden. Our estimated burden for the
information collection reflects an overall decrease of 4,780 hours and
a corresponding decrease of 145 responses. We believe these adjustments
more accurately reflect the current number of requests associated with
postmarket surveillance of medical devices.
Dated: November 1, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-24232 Filed 11-4-22; 8:45 am]
BILLING CODE 4164-01-P
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